> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ivonescimab-in-combination-with-enfortumab-940f4019-aebf-46a7-bea8-4a396c3dfca1 > Record changed: 2026-11-04 # A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma NCT07815665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) Participants 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) Lead sponsor Summit Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) Start date 2026-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Title and summary **Summary** A Randomized, Open-Label, Multicenter, Phase 2/3 Clinical Study of Ivonescimab in Combination with Enfortumab Vedotin vs Pembrolizumab in Combination with Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Acronym** HARMONi-GU1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Short title** A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Official title** A Randomized Phase 2/3 Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (HARMONi-GU1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Dates **Completion date** 2030-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **First posted** 2026-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Registry last updated** 2026-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Primary completion date** 2030-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Start date** 2026-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Size and sites **Participants** 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Planned participants** 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Lead sponsor** Summit Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Identifiers **Registry ID** NCT07815665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **ClinicalTrials.gov ID** NCT07815665 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Outcomes ### Primary outcomes 1. Phase 2 Primary Outcome Measure Timeframe: Through 90 days after the last study treatment Adverse events (AEs) as characterized by type, incidence, severity, seriousness, and relationship to study treatment 2. Phase 2 Primary Outcome Measure Timeframe: From first dose until approximately 30 days after the last study treatment, assessed up to 3 years Number of participants with clinical laboratory abnormalities 3. Phase 2 Primary Outcome measure Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years Objective response rate (ORR) 4. Phase 2 Primary Outcome Measure Timeframe: From first dose until end of treatment, assessed up to 3 years PK characteristics: ivonescimab serum concentration profiles 5. Phase 3 Primary Outcome Measure Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. PFS per RECIST v1.1 by Independent Radiology Review Committee (IRRC) 6. Phase 3 Primary Outcome Measure Timeframe: From date of randomization until the end of study, assessed up to 4 years Overall Survival (OS) ### Secondary outcomes 1. Phase 2 Secondary Outcome Measure Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years PFS per RECIST v1.1 by investigator 2. Phase 2 Secondary Outcome Measure Timeframe: From date of randomization until the end of study, assessed up to 4 years Overall Survival (OS) 3. Phase 2 Secondary Outcome Measure Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years Duration of Response (DOR) 4. Phase 2 Secondary Outcome Measure Timeframe: From time of initiation of first dose to 30 days after end of treatment. Incidence of anti-drug antibodies (ADA) against ivonescimab 5. Phase 3 Secondary Outcome Measure Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years ORR 6. Phase 3 Secondary Outcome Measure Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years DOR 7. Phase 3 Secondary Outcome Measure Timeframe: Through 90 days after the last study treatment AEs as characterized by type, incidence, severity, seriousness, and relationship to study treatment 8. Phase 3 Secondary Outcome Measure Timeframe: From first dose until approximately 30 days after the last study treatment, assessed up to 3 years Number of participants with clinical laboratory abnormalities 9. Phase 3 Secondary Outcome Measure Timeframe: From first dose until end of treatment, assessed up to 3 years PK characteristics: ivonescimab serum concentration profiles 10. Phase 3 Secondary Outcome Measure Timeframe: From time of initiation of first dose to 30 days after end of treatment Incidence of ADA against ivonescimab Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 18 years and older - ECOG 0-1 - Life expectancy ≥ 6 months - Histologically documented unresectable LA/mUC (transitional cell carcinoma) of the bladder, renal pelvis, ureter, or urethra with ≥50% urothelial carcinoma component - No prior systemic therapy for LA/mUC - At least one measurable non-cerebral lesion according to RECIST v1.1 - Adequate organ function ### Exclusion criteria - Locally advanced disease that is resectable or suitable for local therapy with curative intent. - Tumors containing any small cell or neuroendocrine differentiation - Ongoing sensory or motor neuropathy Grade 2 or higher. - Radiographic findings consistent with a high risk of bleeding - History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction, extensive bowel resection within 6 months prior to first dose. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Sites - Research SitePhoenix, United StatesNot yet recruiting - Research SiteLos Angeles, United StatesRecruiting - Research SiteWashington D.C., United StatesNot yet recruiting - Research SiteJacksonville, United StatesNot yet recruiting - Research SiteRochester, United StatesNot yet recruiting - Research SiteNashville, United StatesNot yet recruiting - Research SiteSpokane, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815665) ## Related records ### Drugs (3) - [Enfortumab vedotin](https://trialight.com/data/asset/enfortumab-vedotin-45d2083d-a27b-4009-b0c7-61fe813e5dea.md) - [Ivonescimab](https://trialight.com/data/asset/ivonescimab-abc25b61-44c5-4a6f-99eb-c59828f17211.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Summit Therapeutics](https://trialight.com/data/company/summit-therapeutics-90e22a13-4ed3-42cf-b081-43a343878f39.md) ### Conditions (1) - [Transitional cell carcinoma](https://trialight.com/data/condition/transitional-cell-carcinoma-19611feb-3997-59b1-ad3d-49b845cbe40f.md) Primary condition ### Targets (17) - [NECTIN4](https://trialight.com/data/target/nectin4-2a0472c2-ddd1-57a8-b5dd-85f1a66f5d52.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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